BEUDAMED
    FDA Enforcement Class II Terminated

    LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.

    Recall: Z-0388-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0388-2016
    Event ID
    72534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LeMaitre Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2015
    Initiation Date
    October 21, 2015
    Classification Date
    December 4, 2015
    Termination Date
    July 12, 2019
    Address
    63 2nd Ave, N/A, Burlington, MA, 01803-4413, United States

    Description

    LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.

    Reason

    Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.

    Code Info

    Lot Number: SLC3673¿SLC3637 SLC3637¿SLC3666 SLC3676¿SLC3689¿

    Distribution

    Worldwide Distribution. US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain, Switzerland, Sweden, THAILAND, United Kingdom, United Arab Emirates, and VIETNAM.

    Quantity

    4315 total